22904 Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 

and http://www.fda.gov/ 

TobaccoProducts/GuidanceCompliance

RegulatoryInformation/default.htm. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined in 

44 U.S.C. 3502(3) and 5 CFR 1320.3(c) 

and includes Agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires Federal Agencies 

to provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Draft Guidance on Establishing That a 

Tobacco Product Was Commercially 

Marketed in the United States as of 

February 15, 2007—(OMB Control 

Number 0910–NEW) 

This draft guidance provides 

information on how a manufacturer may 

establish that a tobacco product was 

commercially marketed in the United 

States as of February 15, 2007, and is, 

therefore, a grandfathered product not 

subject to premarket review. The draft 

guidance recommends that the 

manufacturer provide evidence that may 

include, among other things, dated 

copies of advertisements, dated catalog 

pages, dated promotional material, and 

dated bills of lading. FDA recommends 

that the manufacturer submit as much 

information as possible to demonstrate 

that the tobacco product was 

commercially marketed in the United 

States as of February 15, 2007. FDA’s 

estimate of the number of respondents 

is based on the fact that requesting an 

agency determination of the 

grandfathered status of a tobacco 

product under the draft guidance is not 

required and also on indications of 

interest in making such request. The 

number of hours is FDA’s estimate of 

how long it might take one to review, 

gather, and submit dated information if 

making a request for an agency 

determination. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ONE TIME REPORTING BURDEN 1

Activity Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

Submit evidence of commercial marketing in the United 

States as of February 15, 2007 ....................................... 150 1 150 10 1,500 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 15, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–9939 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–F–0225] 

Ferm Solutions, Inc.; Filing of Food 

Additive Petition (Animal Use); 

Erythromycin Thiocyanate 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that Ferm Solutions, Inc., has filed a 

petition proposing that the food additive 

regulations be amended to provide for 

the safe use of erythromycin thiocyanate 

as an antimicrobial processing aid in 

fuel-ethanol fermentations with respect 

to its consequent presence in byproduct 

distiller grains used as an animal feed 

or feed ingredient. 

DATES: Submit either electronic or 

written comments on the petitioner’s 

environmental assessment by May 25, 

2011. 

ADDRESSES: Submit electronic 

comments to: http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Isabel W. Pocurull, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6853, email: isabel.pocurull@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

Federal Food, Drug, and Cosmetic Act 

(section 409(b)(5) (21 U.S.C. 348(b)(5)), 

notice is given that a food additive 

petition (FAP 2271) has been filed by 

Ferm Solutions, Inc., P.O. Box 203, 445 

Roy Arnold Ave., Danville, KY 40423. 

The petition proposes to amend the food 

additive regulations in part 573 Food 

Additives Permitted in Feed and 

Drinking Water of Animals (21 CFR part 

573) to provide for the safe use of 

erythromycin thiocyanate as an 

antimicrobial processing aid in fuelethanol fermentations with respect to its 


jdjones on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 79 / Monday, April 25, 2011 / Notices 22905 

consequent presence in byproduct 

distiller grains used as an animal feed 

or feed ingredient. 

The potential environmental impact 

of this action is being reviewed. To 

encourage public participation 

consistent with regulations issued under 

the National Environmental Policy Act 

(40 CFR 1501.4(b)), the Agency is 

placing the environmental assessment 

submitted with the petition that is the 

subject of this notice on public display 

at the Division of Dockets Management 

(see DATES and ADDRESSES) for public 

review and comment. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

FDA will also place on public display 

any amendments to, or comments on, 

the petitioner’s environmental 

assessment without further 

announcement in the Federal Register. 

If, based on its review, the Agency finds 

that an environmental impact statement 

is not required and this petition results 

in a regulation, the notice of availability 

of the Agency’s finding of no significant 

impact and the evidence supporting that 

finding will be published with the 

regulation in the Federal Register in 

accordance with 21 CFR 25.51(b). 

Dated: April 15, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2011–9913 Filed 4–22–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0431] 

Guidance for Food and Drug 

Administration Staff and Tobacco 

Retailers on Civil Money Penalties and 

No-Tobacco-Sale Orders for Tobacco 

Retailers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘Civil 

Money Penalties and No-Tobacco-Sale 

Orders for Tobacco Retailers.’’ This 

guidance document describes FDA’s 

current policies with respect to civil 

money penalties and no-tobacco-sale 

orders for retailers who violate 

requirements of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

relating to tobacco products, including 

the FD&C Act requirement that tobacco 

products may not be sold or distributed 

in violation of FDA’s ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ With 

the release of this final guidance 

document, several provisions in the 

Family Smoking Prevention and 

Tobacco Control Act (the Tobacco 

Control Act) that relate to civil money 

penalties and no-tobacco-sale orders 

become effective. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance entitled 

‘‘Civil Money Penalties and No-TobaccoSale Orders for Tobacco Retailers’’ to the 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request or include a fax number to 

which the guidance document may be 

sent. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Gerie A. Voss, Center for Tobacco 

Products, Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD 20850, 1–877–287–1373, 

gerie.voss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for FDA staff and tobacco 

retailers entitled ‘‘Civil Money Penalties 

and No-Tobacco-Sale Orders for 

Tobacco Retailers.’’ On June 22, 2009, 

President Obama signed the Tobacco 

Control Act (Pub. L. 111–31) into law. 

The Tobacco Control Act grants FDA 

important new authority to regulate the 

manufacture, marketing, and 

distribution of tobacco products to 

protect the public health generally and 

to reduce tobacco use by minors. 

Among its many provisions, the 

Tobacco Control Act authorizes FDA to 

impose civil money penalties for 

violations of the FD&C Act requirements 

that relate to tobacco products (section 

303(f)(9) of the FD&C Act (21 U.S.C. 

333(f)(9)). Of special interest to retailers, 

one of the FD&C Act’s requirements is 

that tobacco products may not be sold 

or distributed in a manner that violates 

regulations issued under section 906(d) 

of the FD&C Act (21 U.S.C. 387f(d)), 

such as the ‘‘Regulations Restricting the 

Sale and Distribution of Cigarettes and 

Smokeless Tobacco to Protect Children 

and Adolescents’’ that were published 

by FDA on March 19, 2010 (75 FR 

13225) (21 CFR part 1140). The Tobacco 

Control Act also authorizes FDA to 

impose a no-tobacco-sale order on a 

retail outlet for repeated violations of 

regulations issued under section 906(d) 

of the FD&C Act, and discusses a 

number of technical and procedural 

issues relating to civil money penalties 

and no-tobacco-sale orders. 

This guidance document describes the 

penalty structure and FDA policies with 

respect to civil money policies and notobacco-sale orders. With the release of 

this final guidance document, several 

Tobacco Control Act provisions that 

relate to civil money penalties and notobacco-sale orders become effective 

(section 103(q)(3) of the Tobacco 

Control Act). 

In the Federal Register of August 31, 

2010 (75 FR 53316), FDA announced the 

availability of the draft guidance of the 

same title dated August 2010. FDA 

received a few comments on the draft 

guidance, and those comments were 

considered as the guidance was 

finalized. In addition, editorial changes 

were made to improve clarity. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on ‘‘Civil Money 

Penalties and No-Tobacco-Sale Orders 

for Tobacco Retailers.’’ It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 


jdjones on DSKHWCL6B1PROD with NOTICES